Define
Requirements, risks, and evidence for the next build gate.
Hardware Form / Quality
Systems · traceability · audits
Quality and certifications
Quality is measurable acceptance criteria and traceability—not a slide in a pitch deck.
Hardware Form operates under ISO 9001 and ISO 13485 quality systems and BSCI social compliance. We have taken products through UL as part of client programs. Exact certificate numbers and scope statements are provided under NDA when needed for your vendor qualification.
Certifications
| Standard | Role |
|---|---|
| ISO 9001 | Quality management system |
| ISO 13485 | Medical device QMS (where applicable programs) |
| BSCI | Supply chain social compliance |
| UL | We have taken products through UL; product listings are client-specific |
Certificate numbers and scope letters are shared during vendor qualification. Production detail: Testing and quality · Certification readiness.
Quality FAQ
Can you share audit reports?
Summary letters and scope statements are available under mutual NDA for active programs.
Quality and certifications
One accountable program from architecture through production. Hardware Form runs ISO 9001 and ISO 13485 quality systems with BSCI supply-chain compliance. We have taken products through UL as part of client programs; listings remain product-specific.
Operations scale with roughly 400 staff across engineering and manufacturing. See quality and certifications.
Build
Integrated prototypes with production-relevant materials and test.
Validate
Functional, environmental, and manufacturing readiness checks.
Scale
NPI, yield tracking, and controlled ramp on our lines.